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Trial record 3 of 32 for:    Dermatophagoides pteronyssinus AND Dermatophagoides farinae

A Study Investigating the Immunologic Effects and Safety of 60-day Treatment of the ALK HDM Tablets in Adult Subjects With HDM-Induced Allergic Rhinitis and/or Atopic Asthma

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ClinicalTrials.gov Identifier: NCT02596321
Recruitment Status : Completed
First Posted : November 4, 2015
Results First Posted : December 18, 2017
Last Update Posted : March 1, 2018
Sponsor:
Collaborators:
Linical Co., Ltd.
Datamap
Information provided by (Responsible Party):
Abbott

Brief Summary:
To demonstrate superiority of ALK HDM tablets versus placebo in immune response, measured as change of D.farinae specific immunoglobulin G4 (IgG4) from baseline to end of treatment with ALK HDM tablets given once daily over 60 days.

Condition or disease Intervention/treatment Phase
Allergy Asthma Rhinitis Drug: Mitizax Drug: Placebo Phase 3

Detailed Description:

To demonstrate superiority of ALK HDM tablets versus placebo in the immune response, measured as change of D. Farinae specific IgG4 from baseline to end of treatment with ALK HDM tablets given once daily over 60 days

To evaluate the immune response, measured as change of D. pteronyssinus, D. farinae specific immunoglobulin E (IgE) and D. pteronyssinus specific IgG4 from baseline to end of treatment with ALK HDM tablets given once daily over 60 days, compared to placebo

To evaluate in patients with HDM-allergic respiratory disease the safety and tolerability of 60-day treatment with ALK HDM tablets compared to placebo


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled Study Investigating the Immunologic Effects and Safety of 60-day Treatment of the ALK HDM Tablets in Adult Subjects With Allergic Rhinitis and/or Atopic Asthma Induced by House Dust Mites
Study Start Date : October 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Odactra

Arm Intervention/treatment
Experimental: Mitizax ALK HDM tablet
Standardised allergen extract from the house dust mites Dermatophagoides pteronyssinus and Dermatophagoides farinae developmental unit, dose standard for ALK HDM tablets (12DU)
Drug: Mitizax
Allergen extract
Other Names:
  • ALK HDM tablet
  • allergen extract

Placebo Comparator: Placebo tablet
Placebo tablet
Drug: Placebo
Placebo tablet
Other Name: Placebo tablet




Primary Outcome Measures :
  1. D. Farinae Specific IgG4 Change From Baseline to End of Treatment [ Time Frame: 60 days from baseline ]
    primary efficacy endpoint of D. Farinae specific IgG4 change from baseline to end of treatment


Secondary Outcome Measures :
  1. D. Pteronyssinus Specific IgG4 Change From Baseline to End of Treatment [ Time Frame: 60 days from baseline ]
    secondary endpoint of D. pteronyssinus specific IgG4 change from baseline to end of treatment

  2. D. Farinae Specific IgE Change From Baseline to End of Treatment [ Time Frame: 60 days from baseline ]
    the secondary endpoint of D. farinae specific IgE change from baseline to end of treatment compared to placebo

  3. D. Pteronyssinus Specific IgE Change From Baseline to End of Treatment [ Time Frame: 60 days from baseline ]
    the secondary endpoint of D. pteronyssinus specific IgE change from baseline to end of treatment compared to placebo



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent obtained before entering the study
  • Patients 18-65 years of age, with a clinical history consistent with HDM-induced allergic rhinitis or allergic rhinoconjunctivitis with or without HDM-induced allergic atopic asthma for more than 1 year
  • Use of symptomatic treatment of HDM-induced allergic rhinitis and/or HDM-induced atopic asthma, i.e. antihistamines, nasal decongestants, nasal and/or inhaled corticosteroid for more than 1 year
  • if HDM-induced atopic asthma is present, it should be of mild to moderate severity, controlled on treatment corresponding to steps 1-3 of The Global initiative for asthma (GINA)
  • Positive skin prick test response (wheal diameter ≥3 mm) to D pteronyssinus and/or D.farinae
  • Moderate or higher level of D.pteronyssinus and/or D.farinae specific IgE (defined as ≥IgE Class 2; or ≥0.70 kilo unit (kU)/L)
  • Patient one of the following:

    1. Male
    2. Female, infertile
    3. Female, with a negative pregnancy test and willingness to practice appropriate contraceptive methods until treatment with study drug has been discontinued.
  • Patient willing and able to comply with study protocol

Exclusion Criteria:

  • Previous treatment with HDM immunotherapy for more than 1 month within the last 5 years
  • Ongoing treatment with any allergen-specific immunotherapy product
  • Reduced lung function (defined as Forced expiratory volume in 1 second (FEV1) < 70% of predicted value after adequate pharmacologic treatment) measured at Visit 1 and Visit 2
  • Clinical history of uncontrolled asthma within 3 months prior to the screening visit
  • Having experienced a severe asthma exacerbation within 3 months prior to screening visit
  • Symptoms of or treatment for upper respiratory tract infection, acute sinusitis, acute otitis media or other relevant infectious process at randomization
  • Inflammatory conditions in the oral cavity with severe symptoms such as oral lichen planus with ulcerations or severe oral mycosis at randomization
  • History of anaphylaxis with cardiorespiratory symptoms (immunotherapy, exercise-induced, food allergy, drugs or an idiopathic reaction)
  • History of recurrent generalized urticaria (defined as two or more episodes) during the last 2 years
  • A history of drug induced (incl. immunotherapy) facial angioedema or a family (parents and siblings) history of hereditary angioedema
  • Any chronic disease (e.g. cystic fibrosis, malignancy, malabsorption or malnutrition, renal or hepatic abnormality or any other diseases that in the opinion of the investigator would interfere with the study evaluations or the safety of the subject)
  • Systemic disease affecting the immune system (e.g. autoimmune disease, immune complex disease, or immune deficiency disease whether acquired or not)
  • Immunosuppressive treatment (ATC code L04 or L01) within 3 months prior to the screening visit
  • Currently treated with tricyclic antidepressants; catecholamine-O-methyltransferase (COMT) inhibitors and mono amine oxidase inhibitors (MAOIs) and beta-blockers including topical administration
  • Use of medication at the screening visit which at the time of skin prick test (SPT) can interfere with the result (i.e. antihistamines)
  • Use of an investigational drug within 30 days/5 half-lives of the drug (which ever longest) prior to the screening visit
  • History of allergy, hypersensitivity or intolerance to a excipient in the investigational medicinal product (except D.Pteronyssinus and D.farinae)
  • Being immediate family of the investigator or study staff, defined as the investigator's/staff's spouse, parent, child, grandparent or grandchild
  • Severe mental disorders that in the opinion of the investigator would interfere with the study evaluations or the safety of the subject
  • Cardiovascular conditions in which complications are possible when using adrenaline
  • Women who are pregnant or breastfeeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02596321


Locations
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Belarus
Minsk Regional Clinical Hospital
Minsk, Belarus, 220041
City Clinical Hopsital #10
Minsk, Belarus, 220096
Russian Federation
Kazan State Medical Academy
Kazan, Russian Federation, 420103
National Research Center - Institute of Immunology Federal Medical-Biological Agency of Russia
Moscow, Russian Federation, 115478
"Russian Medical Academy of Postgraduate Education Studies
Moscow, Russian Federation, 123182
City out-patient's clinic # 94
Saint-Petersburg, Russian Federation, 193231
Smolensk State Medical Academy
Smolensk, Russian Federation
Hospital of Russian Academy of Science
Troitsk, Russian Federation, 142190
Bashkirskiy State Medical University
Ufa, Russian Federation
Sponsors and Collaborators
Abbott
Linical Co., Ltd.
Datamap
Investigators
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Study Director: Dmitri Kazei, MD Abbott

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Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT02596321     History of Changes
Other Study ID Numbers: MITI3001
First Posted: November 4, 2015    Key Record Dates
Results First Posted: December 18, 2017
Last Update Posted: March 1, 2018
Last Verified: February 2018
Keywords provided by Abbott:
House Dust Mite
Additional relevant MeSH terms:
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Asthma
Rhinitis
Rhinitis, Allergic
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Nose Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases